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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA 1% SODIUM HYLURONATE ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS EUFLEXXA 1% SODIUM HYLURONATE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Headache (1880)
Event Date 06/10/2019
Event Type  Injury  
Event Description
First injection of second round of euflxxa. First round was given (b)(6) 2018. After each injection and within first hour i would get severe headache and stomach upset. It would last for about 24 hours. The first injection of second round same. Symptoms but it lasted for a week. We canceled all further injections. Product type: over-the-counter.
 
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Brand NameEUFLEXXA 1% SODIUM HYLURONATE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS
MDR Report Key8837643
MDR Text Key152752874
Report NumberMW5088415
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/26/2019 Patient Sequence Number: 1
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